Submittal IQ
SubmittalIQ unifies all 15+ openFDA endpoints into a single queryable database, enabling pharmaceutical companies, CDMOs, CROs, and life sciences investors to generate complete regulatory risk profiles of any company in minutes instead of weeks. The platform cross-references enforcement actions, adverse events, recalls, and inspections to surface patterns that were previously invisible, and operates as a read-only intelligence layer so client data never enters the system.
- Data & Analytics
- Regulatory & Compliance Technology
- Software Only
- Artificial Intelligence
- Healthcare Technology
Funding
Founders
Founder details are not available yet.
Product
Problem
FDA regulatory intelligence is scattered across 15 separate databases that have never been cross-referenced, forcing pharmaceutical companies, CDMOs, CROs, and investors to manually assemble data from at least eight sources to assess a company's regulatory risk. This process takes weeks or months and still misses the cross-database patterns—such as enforcement actions preceding warning letters or adverse event spikes preceding recalls—that only appear when the data is unified.
Solution
SubmittalIQ is the first platform to unify every openFDA endpoint into a single, queryable database, enabling users to generate a complete regulatory profile of any pharmaceutical or device company in minutes. The platform continuously ingests and normalizes data from 15+ databases covering devices, drugs, biologics, enforcement, adverse events, recalls, labeling, and registrations, cross-referencing everything by company, product, and category. Users can ask questions that were previously impossible to answer, such as identifying enforcement patterns that precede stock movements or inspection findings that precede warning letters. SubmittalIQ operates as a read-only intelligence layer, ensuring that client documents and proprietary data never enter the system, and it is built with input from active FDA consultants and life sciences professionals.
Target Audience
Primary customers are pharmaceutical companies, CDMOs, CROs, and life sciences investors who need comprehensive, cross-referenced FDA regulatory intelligence for due diligence, competitive monitoring, and risk assessment.
Features
- Unified querying across all 15+ openFDA endpoints, including devices, drugs, biologics, enforcement, adverse events, recalls, labeling, and registrations
- Continuous data ingestion and normalization to a consistent schema, cross-referenced by company, product, and category
- Read-only architecture that keeps client submissions and proprietary data out of the system, with SOC 2 certification in progress
- Roadmap includes AI-assisted query interpretation, company regulatory profile dashboards, enforcement signal alerts, and integration with regulatory information management systems
- Developed with direct input from 18 beta testers who are active FDA consultants and life sciences professionals